Evaluation of a Low-cost CPAP Device on Hospitalized COVID-19 Patients (OxyJet-CPAP)

March 24, 2022 updated by: Bangladesh University of Engineering and Technology

Safety and Efficacy Evaluation of a Low-cost CPAP Device for Hypoxemic COVID-19 Patients: A Pilot Study

The aim of this study is to evaluate the preliminary safety and performance of a low-cost locally-made Venturi-based Non-invasive Positive Pressure Ventilator (NIPPV) device for hypoxemic COVID-19 patients. The device administers Continuous Positive Airway Pressure (CPAP) therapy using the jet-mixing or Venturi effect to increase the volume flow rate of oxygenated air from a pressurized cylinder by entraining the atmospheric air. To provide CPAP therapy, this high flow of oxygenated air is delivered to the patient via a low-cost non-vented mask with a tight seal with a High-Efficiency Particulate Air (HEPA) filter connected to the exhalation limb. The tight seal and HEPA filter ensures a minimal risk of aerosol generation and thus the device can be used without a negative pressure room. The system consists of the developed Venturi-based flow-generator, a standard 22mm breathing tube, a standard Y-connector, a non-vented CPAP mask (e.g., snorkel mask, helmet), a HEPA filter, and a Positive End Expiratory Pressure (PEEP) valve. The bench-top testing of the device is done in the laboratories of BUET and was verified that the device performs within the CPAP guidelines provided by the Medicines and Healthcare products Regulatory Agency (MHRA), UK. This study aims to assess the safety of and efficacy of the device in three different steps: (1) design validation, (2) clinical feasibility and (3) pilot clinical trial for safety and efficacy evaluation. Only if the device successfully passes the parts 1 and 2, the investigators will proceed to the final clinical trial in step 3. In this final step, the investigators aim to conduct a randomized controlled trial (RCT) evaluating for non-inferiority of the CPAP intervention compared to standard HFNO treatment. The number of ventilator-free days will be used as the primary outcome for efficacy, while patient recovery, death, or need of intubation and other adverse events will be used as secondary outcomes.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
45

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bangladesh
      • Dhaka, Bangladesh, 1000
        • Dhaka Medical College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age ≥ 18 years
  • Confirmed or suspected COVID-19 patient (by RT-PCR) having severe pneumonia and hypoxemia (SpO2 ≤90%) who did not respond to standard oxygen therapy (non-rebreather mask on 15L/min at 100% FiO2).

Exclusion Criteria:

  • Severely hypoxemic patients (SpO2≤85%)
  • Patients with low respiratory drive or requiring cardiopulmonary resuscitation
  • Patients with contraindications for CPAP
  • Pregnant status
  • Age > 65 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: High Flow Nasal Oxygen (HFNO) treatment
Device: High Flow Nasal Oxygen (HFNO) treatment
Administration of High Flow Nasal Oxygen (HFNO) to patients who did not respond to standard low-flow oxygen therapy (non-rebreather mask on 15L/min). Adjust flow-rate and FiO2 as per standard HFNO treatment protocol.
Experimental: Continuous positive airway pressure (CPAP) therapy using OxyJet
Device: Continuous Positive Airway Pressure (CPAP) therapy using OxyJet
Administer CPAP to patients who did not respond to standard low-flow oxygen therapy (non-rebreather mask on 15L/min). CPAP initiated with FiO2 at 40% and a 10cm PEEP. Titrate PEEP to 15 cm if required. Deliver additional oxygen via secondary port if a higher FiO2 is required.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of ventilator-free days
Time Frame: 10 days
The total number of days the patient was able to avoid being placed under a mechanical ventilator.
10 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Recovery of the patient
Time Frame: 30 days
The event that the patient has recovered and released from the hospital within 30 days.
30 days
Death or need of intubation
Time Frame: 10 days
The event that the patient dies or requires to be placed under a mechanical ventilator.
10 days
Oxygen toxicity or other adverse events
Time Frame: 10 days
Oxygen toxicity or other adverse event rating according to the CTCAE scale (1-5)
10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bangladesh University of Engineering and Technology

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Dhaka Medical College

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Dr. Taufiq Hasan, PhD, Bangladesh University of Engineering and Technology
  • Principal Investigator: Dr. Robed Amin, MBBS, FCPS, Dhaka Medical College

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 17, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 9, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 9, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 22, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 22, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 23, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BME-BUET-003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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